Renal neuromodulation for treatment of human patients

• US 10,111,707 B2
• Filed: 06/15/2017
• Issued: 10/30/2018
• Est. Priority Date: 04/08/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Zarins, Denise, Gifford, III, Hanson, Deem, Mark, Levin, Howard R., Gelfand, Mark, Zadno, Nicolas
• Primary Examiner(s): Bockelman, Mark W
• Application Number:
  US15/623,428
• Publication Number:
  US 20170348050A1
• Time in Patent Office: 502 Days
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2018/00059 Material properties
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61N 1/05 : for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/327 : for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36117 : for treating hypertension
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: H05K 999/99 : dummy group

Abstract

Methods and apparatus are provided for monopolar neuromodulation, e.g., via a pulsed electric field. Such monopolar neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, monopolar neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such monopolar neuromodulation is performed bilaterally.

Claims

1. A method, comprising:

intravascularly positioning a catheter in a reduced profile delivery configuration at a treatment site within a renal artery of a human patient and adjacent to renal nerves;

at the treatment site, transforming an expandable member at a distal portion of the catheter between the reduced profile delivery configuration and a treatment configuration,

wherein, in the treatment configuration, the expandable member is sized and shaped to place a plurality of electrodes arranged thereabout into apposition with an inner wall of the renal artery of the patient;

selectively energizing a first electrode group of the expandable member to deliver a bipolar energy field to the renal nerves; and

selectively energizing a second electrode group at the distal portion of the catheter to deliver a unipolar energy field to the renal nerves,

wherein delivering the bipolar energy field and the unipolar energy field modulates neural signaling along the renal nerves, and

wherein modulating neural signaling along the renal therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein the bipolar energy field is generated by two or more electrodes carried by the expandable member.

3. The method of claim 1 wherein the unipolar energy field is generated between one or more electrodes carried by the expandable member and a unipolar electrode carried by a shaft of the catheter and positioned proximate to the expandable member.

4. The method of claim 1 wherein the treatment site is a first treatment site, the bipolar energy field is a first bipolar energy field, and the unipolar energy field is a first unipolar energy field, and wherein the method further comprises:

at the first treatment site, transforming the expandable member between the treatment configuration and the reduced profile delivery configuration;

distally repositioning the catheter to a second treatment site different than the first treatment site;

at the second treatment site, transforming the expandable member between the reduced profile delivery configuration and the treatment configuration, for a second treatment;

selectively energizing the first electrode group and delivering a second bipolar energy field to the renal nerves at the second treatment site; and

selectively energizing the second electrode group and delivering a second unipolar energy field to the renal nerves at the second treatment site,

wherein delivering the second bipolar energy field and second unipolar energy field further modulates neural signaling along the renal nerves.

5. The method of claim 1 wherein the expandable member comprises a balloon, and wherein transforming the balloon between the reduced profile delivery configuration and the treatment configuration comprises expanding the balloon such that electrodes arranged thereabout are placed into contact with the inner wall of the renal artery.

6. The method of claim 5 wherein, when the balloon is in the treatment configuration, blood flow is occluded within the renal artery.

7. The method of claim 1, further comprising monitoring a parameter of the catheter and/or tissue within the patient before and during delivery of the bipolar energy field and the unipolar energy field.

8. The method of claim 7, further comprising altering delivery of at least one of the bipolar energy field and the unipolar energy field in response to the monitored parameter.

9. The method of claim 7 wherein monitoring a parameter comprises monitoring a thermal response of the tissue, and wherein the method further comprises maintaining the desired thermal response of the tissue during delivery of the bipolar energy field and the unipolar energy field.

10. The method of claim 1 wherein delivering the bipolar energy field and the unipolar energy field to the renal nerves comprises at least partially ablating one or more renal nerves of the patient.

11. The method of claim 1 wherein delivering the bipolar energy field and the unipolar energy field to the renal nerves comprises thermally altering the renal nerves in a manner that reduces neural traffic to and from a kidney of the patient.

12. A method for treating a hypertensive human patient, the method comprising:

positioning an expandable member of a renal denervation catheter at an intravascular location within a renal artery of a human patient and adjacent to neural fibers innervating a kidney of the patient for a treatment,

wherein the catheter includes a plurality of first electrodes carried by the expandable member and a second electrode carried by a shaft of the catheter proximate the expandable member;

transforming the expandable member between a low-profile delivery state and an expanded treatment state,

wherein, in the treatment state, the expandable member is sized and shaped to place the first electrodes into contact with a wall of the renal artery; and

ablating the neural fibers innervating the kidney via radio frequency (RF) energy delivered in a bipolar fashion using the first electrodes and RF energy delivered in a unipolar fashion using the second electrode,

wherein ablating the neural fibers innervating the kidney via RF energy results in a therapeutically beneficial reduction in blood pressure of the hypertensive patient.

13. The method of claim 12 wherein ablating the neural fibers innervating the kidney via RF energy comprises ablating the neural fibers using a combination of (a) bipolar energy delivery from the bipolar electrodes carried by the expandable member and (b) unipolar energy delivery from the unipolar electrode and one or more of the bipolar electrodes carried by the expandable member.

14. The method of claim 12 wherein positioning an expandable member of a renal denervation catheter at an intravascular location within a renal artery comprises positioning a balloon carrying the plurality of first electrodes within the renal artery of the patient.

15. The method of claim 12, further comprising monitoring a parameter of the renal denervation catheter and/or tissue within the patient before and during delivery of the RF energy and altering delivery of the RF energy in response to the monitored parameter.

16. The method of claim 15 wherein monitoring a parameter comprises monitoring temperature, power, and/or impedance.

17. The method of claim 12, further comprising removing the renal denervation catheter from the patient after ablating the neural fibers.